OncoMatch/Clinical Trials/NCT05635643
Study of CHS-114 in Participants With Advanced Solid Tumors
Is NCT05635643 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CHS-114 and toripalimab for advanced solid tumor.
Treatment: CHS-114 · toripalimab — This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (results from baseline PD-L1 IHC assay score required)
Consent to provide HPV status assessed by p16 and results from baseline PD-L1 IHC assay score
Disease stage
Required: Stage III, IV
locally advanced or metastatic (Stage IV) solid tumor; histologically or cytologically confirmed advanced or metastatic HNSCC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — advanced/metastatic HNSCC
progressed during or after a platinum-based chemotherapy
Must have received: anti-PD-1 therapy — advanced/metastatic HNSCC
progressed during or after a programmed cell death receptor (PD)-1 or PD ligand 1 (PD-L1) targeting agent
Must have received: anti-PD-L1 therapy — advanced/metastatic HNSCC
progressed during or after a programmed cell death receptor (PD)-1 or PD ligand 1 (PD-L1) targeting agent
Cannot have received: CCR8 inhibitor
Previously received an anti-CCR8 antibody or anti-CCR8 targeted therapy
Lab requirements
Blood counts
absolute neutrophil count 1.0 10^9/L, hemoglobin 8.0 g/dL, and platelet count 75 10^9/L
Kidney function
Serum creatinine clearance 30 mL/min per Cockcroft-Gault formula
Liver function
Total bilirubin 1.5 ULN ( 3 ULN if elevated because of liver metastases or documented Gilbert's syndrome); AST/SGOT and ALT/SGPT < 2.5 ULN or < 5 ULN for patients with known liver metastases
Cardiac function
Ejection fraction 50%, as measured by echocardiogram, multigated acquisition scan, nuclear stress test, or equivalent modality
Serum creatinine clearance 30 mL/min per Cockcroft-Gault formula. Total bilirubin 1.5 ULN ( 3 ULN if elevated because of liver metastases or documented Gilbert's syndrome). AST/SGOT and ALT/SGPT < 2.5 ULN or < 5 ULN for patients with known liver metastases. Adequate hematologic function, defined as absolute neutrophil count 1.0 10^9/L, hemoglobin 8.0 g/dL, and platelet count 75 10^9/L. Ejection fraction 50%, as measured by echocardiogram, multigated acquisition scan, nuclear stress test, or equivalent modality.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Hoag Memorial Hospital · Newport Beach, California
- FOMAT Medical Research · Oxnard, California
- Stanford Cancer Center · Palo Alto, California
- SCRI Lake Nona DDU (FL Cancer Specialists) · Orlando, Florida
- Emory Winship Cancer Institute · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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